Transcatheter aortic valve replacement (TAVR) was more costly upfront than surgical AVR (SAVR), but total 2-year costs were about $2000 lower in low-surgical risk patients with severe aortic stenosis in the pivotal PARTNER 3 trial, new research shows.
TAVR was projected to be a “highly cost-effective” therapy over a lifetime compared with SAVR, assuming no major differences in survival or costs beyond 2 years.
That’s an important caveat, acknowledged lead author David J. Cohen, MD, director of clinical and outcomes research at the Cardiovascular Research Foundation (CRF) in New York City. Because the cost difference is relatively small between the two approaches, he noted that the results are very sensitive to differences in long-term mortality, such that even a 4% to 5% higher mortality for TAVR would flip the results and SAVR would become the cost-effective alternative.
“Given the importance of long-term outcomes in these projections, 10-year follow-up is ongoing and will ultimately determine the optimal strategy for such patients from both a clinical and economic perspective,” Cohen concluded during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT) 2021, sponsored by the CRF.
Previous analyses have shown that TAVR is cost-effective compared with SAVR in patients with severe aortic stenosis at high and intermediate surgical risk, but data are lacking in low-risk patients, a group for which TAVR was recently approved in the United States.
For the study, costs were assessed based on a combination of resource utilization for the initial TAVR and SAVR procedures in 929 patients and Medicare claims for all other costs through 2 years. Valve price was based on their current acquisition costs of $32,500 for TAVR and $5,900 for SAVR.
During the index hospitalization, TAVR using the Sapien 3 valve (Edwards Lifesciences) was associated with a 2.5-hour reduction in procedure time (59 vs 208 min) and 4.5-day reduction in length of stay (1.9 vs 6.5 days), two days of which were ICU days. In addition, more TAVR patients were discharged home with self-care (96% vs 73%), said Cohen, also with St. Francis Hospital and Heart Center in Roslyn, New York.
Index hospitalization was about $19,000 higher for TAVR patients ($37,370 vs $18,327), driven by the higher price of the valve. Although the remaining hospital costs and physician costs were lower with TAVR, overall hospitalization costs were $591 lower with surgery ($46,606 vs $47,196; P = .59).
During follow-up, there were significant cost savings with TAVR, compared with SAVR, from discharge to 30 days (–$3896) and from 30 days to 6 months (–$1506; P <.05 for both), driven by fewer hospital and rehabilitation days.
There were signs of catch up, however. Costs were higher with TAVR by $1072 from 6 to 12 months and by $1710 from 12 to 24 months, although these trends did not reach statistical significance, Cohen said. Thus, total 2-year follow-up costs were $2620 less for TAVR than for surgery ($19,638 vs $22,258; P = .13).
When combined with the index hospitalization costs, the overall 2-year costs were reduced by $2020 with TAVR, compared with surgery ($66,834 vs $68,864; P = .31).
TAVR was also associated with benefits in usual activities on the EQ-5D index and small gains in life expectancy over the 2 years. When combined, there was a gain of 0.05 total quality-adjusted life-years (QALYs) with TAVR (1.71 vs 1.66; P = .06).
In a formal cost-effectiveness analysis, TAVR was projected to reduce total medical-care costs by $2193 per patient and increase QALY by 0.049 years per patient.
Additionally, TAVR was projected to be an economically dominant strategy with a probability of 84% and had a 95% probability of being cost-effective compared with surgery, based on an incremental cost-effectiveness ratio of less than $50,000/QALY.
Subgroup analyses suggested TAVR was most cost-effective in patients who had New York Heart Association class 3 or 4 heart failure and those with a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 70. Cost savings at 2 years in these patients were $7364 and $6012, respectively, compared with just $605 in women undergoing TAVR.
“It was a little less likely to be dominant in the women but some of that is just due to the fact that that there were twice as many men as women in the trial,” Cohen told theheart.org | Medscape Cardiology. “So I wouldn’t overinterpret that and I also wouldn’t overinterpret the New York Heart Association or KCCQ, although from my speaking to a number of surgeons, they were not surprised by that because these are the patients who are sicker and have more symptoms and may struggle a bit.”
“These findings are incredibly reassuring,” panelist Suzanne J. Baron, MD, Beth Israel Lahey Health, Burlington, Massachusetts, said during a discussion of the results. “We know that our patients do well with TAVR, particularly in the low-risk population, and we’ve seen that the cost-effectiveness of this technology is improving over time as we go to lower and lower risk patients.”
Baron asked whether they had planned an analysis looking at valve durability, noting that it will likely affect cost, as well as quality of life, over time.
Cohen said they had not. “And the reason for that is that, quite frankly, there is so much uncertainty as we treat these low-risk patients with regard to durability, and the cost difference we’re dealing with right now is not a very, very large amount. So what we felt was the best way to capture this was to look at mortality.”
He also pointed out that the price of TAVR valves will come down as more valves are developed around the world. Indeed, the analysis showed a cost savings of $9653 if the price of the TAVR valve dropped in the future to $25,000.
During a press briefing, Luca Testa, MD, PhD, IRCCS Policlinico S. Donato, Milan, Italy, said he was reassured by the economic results and by 5-year data presented at the meeting from the SURTAVI trial in intermediate-risk patients. “But I must say the picture is still incomplete, because in order to have a final word, we need to see the application of the durability concept.”
He noted that data on surgical valves go out 15 years or even more. “But this is not the case for TAVR. So in other words, I would like to see and wait for a final word coming from long-term follow-up.”
When interviewed, Cohen said the durability question is much more open in the low-risk patients than in the intermediate-risk patients where, as of today, “we have great data 5-year from the SURTAVI trial.
“I think the durability question is gradually being answered, but given that the life expectancy for a 74-year-old patient, as was enrolled in this trial, is about 12 years, we really need more data on durability to be really certain,” he added.
PARTNER 3 and the economic analysis were funded by grants from Edwards Lifesciences. Cohen reports institutional grant support or research contracts with Boston Scientific, Edwards Lifesciences, Medtronic, Abbott Vascular, Volcano, Svelte, Corvia, and Saranas; personal grant support or research contracts with Ancora Heart; and consultant fee/honoraria/speaker’s bureau participation with Medtronic, Abbott Vascular, Boston Scientific, and Edwards Lifesciences.
Transcatheter Cardiovascular Therapeutics (TCT) 2021. Presented November 5, 2021.
Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.
Source: Read Full Article
